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GLP Regulations and Compliance Flashcards

6 cards from real SQA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 GLP Regulations and Compliance flashcards as text

  1. What does the EPA's GLP standard under TSCA (40 CFR Part 792) primarily apply to?

    Answer: Health and environmental effects studies submitted under TSCA

    40 CFR Part 792 applies to nonclinical health and environmental effects studies submitted to the EPA under the Toxic Substances Control Act.

  2. Under GLP regulations, what must accompany each final study report to certify compliance?

    Answer: A Quality Assurance Statement

    A Quality Assurance Statement signed by the QAU must be included in the final report to document compliance inspections.

  3. Which term describes a written record that permanently documents a change or correction to raw data under GLP?

    Answer: Audit trail

    An audit trail is the GLP-required record showing who made a change to raw data, when, and why.

  4. Under GLP, which document provides the overall plan for a nonclinical study including objectives and methods?

    Answer: Protocol

    The protocol is the formal document that outlines the study's purpose, design, methods, and statistical analysis plan.

  5. What is the purpose of the Master Schedule Sheet in a GLP-compliant facility?

    Answer: To provide an inventory of all studies conducted at the facility

    The Master Schedule Sheet is a summary of all studies conducted at the test facility, used to assess workload and track study status.

  6. Which GLP requirement mandates that laboratory equipment be periodically inspected, cleaned, and maintained?

    Answer: Equipment calibration and maintenance requirements under 21 CFR 58.63

    21 CFR 58.63 requires that equipment used in GLP studies be adequately maintained, cleaned, and calibrated.

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